MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)
MATAO
7 other identifiers
interventional
540
3 countries
53
Brief Summary
The purpose of this study is to evaluate the efficacy of addition of letrozole to the standard maintenance therapy in subjects following a primary diagnosis of Estrogen-receptor (ER) positive high and low grade epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) and subsequent primary treatment surgery and chemotherapy. Half of the participants will receive to the standard maintenance treatment, letrozole, whilst the other half receives placebo. The study's primary hypothesis is that the treatment with letrozole increases progression free survival in comparison to the maintenance standard treatment (superiority trial).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2020
Longer than P75 for phase_3
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2019
CompletedFirst Posted
Study publicly available on registry
October 2, 2019
CompletedStudy Start
First participant enrolled
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2032
September 29, 2025
September 1, 2025
6.7 years
September 30, 2019
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) for each study group
PFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression. Assessment of progression (recurrence) is generally indicated by SYMPTOMS and will be assessed by the investigator most commonly on the basis of CT scans of the pelvis, abdomen and thorax, according to RECIST v1.1 criteria recommended and mostly presented by an elevated CA-125 level. Elevated CA-125 levels alone shouldn't be considered as progression. Progression assessment according to local standard of care, however, is similarly acceptable.
Up to approximately 12 years
Secondary Outcomes (6)
Overall survival (OS) for each study group
Up to approximately 12 years
Quality-adjusted progression free survival (QAPFS) for each study group
Up to approximately 12 years
Time to first subsequent treatment (TFST) for each study group
Up to approximately 12 years
Quality-adjusted time without symptoms of toxicity (Q-TWiST) for each study group
Up to approximately 12 years
Health related quality of life (QoL) assessed byFunctional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire for each study group
Up to approximately 5.25 years
- +1 more secondary outcomes
Study Arms (2)
Letrozole (aromatase inhibitor)
EXPERIMENTALLetrozole, 2.5 mg Femara tablet, administered once daily for 5 years or until symptoms of toxicity or progression of underlying disease
Placebo
PLACEBO COMPARATORPlacebo tablet of Femara (without aromatase inhibitor), 0 mg Femara tablet, administered once daily for 5 years or progression of underlying disease
Interventions
Eligibility Criteria
You may qualify if:
- Patients must be ≥ 18 years of age
- Willing and able to attend the visits and to understand all study-related procedures.
- Primary, newly diagnosed FIGO Stage II to IV and histologically confirmed low or high grade serous or endometrioid epithelial ovarian/fallopian tube/peritoneal cancer
- (Interval-) debulking performed ECOG-Performance Status 0-2
- Signed informed consents (ICF-1; ICF-2)
- Paraffin-embedded tissue or paraffin-embedded cell block (from ascites) available
- Positivity (≥ 1%) for ER expression (only determined by Histopathology Core Facility of MATAO trial)
- At least 4 cycles of platinum-based chemotherapy (neoadjuvant allowed)
- Negative serum pregnancy test in women of childbearing potential who will get/have gotten a surgical resection or radiation sterilization, prior to the intervention in the therapeutical maintenance setting.
You may not qualify if:
- Progressive disease at the end of adjuvant treatment as defined in chapter 9.2.1 of protocol
- Women of childbearing potential (not having undergone a surgical or radiation sterilization and not getting a surgical resection, prior to the intervention in the therapeutical maintenance setting)
- Pregnant or lactating women
- Any other malignancy within the last 5 years which has impact on the prognosis of the patient
- \< 4 cycles of chemotherapy in total
- Contraindications to endocrine therapy
- Inability or unwillingness to swallow tablets
- Patients with a known intolerance to galactose, lactase deficiency and glucose-galactose malabsorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swiss GO Trial Grouplead
- AGO Study Groupcollaborator
- Arbeitsgemeinschaft Gynaekologische Onkologie Austriacollaborator
- Reliable Cancer Therapiescollaborator
- Krebsliga Schweizcollaborator
- Stiftung Guido Fegercollaborator
- Hoffmann-La Rochecollaborator
- Helsana AGcollaborator
- Novartis Pharmaceuticalscollaborator
- Anticancer Fund, Belgiumcollaborator
Study Sites (53)
Krankenhaus der Barmherzigen Brüder Graz
Graz, 8020, Austria
Medizinische Universität Graz
Graz, 8036, Austria
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
Landeskrankenhaus Hochsteiermark Leoben
Leoben, 8700, Austria
Ordensklinikum Linz Barmherzige Schwestern
Linz, 4010, Austria
Universitätsklinikum Salzburg
Salzburg, 5020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Klinik Hietzing Wien
Vienna, 1130, Austria
Charité - Universitätsmedizin Berlin Campus Virchow Klinikum
Berlin, 13353, Germany
St. Elisabeth-Krankenhaus
Cologne, 50935, Germany
Donauisar Klinikum
Deggendorf, 94469, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Evangelische Kliniken Essen Mitte GmbH
Essen, 45136, Germany
Klinikum Esslingen
Esslingen am Neckar, 73730, Germany
University Hospital Freiburg
Freiburg im Breisgau, 79106, Germany
The University Medical Center Hamburg-Eppendorf
Hamburg, 20251, Germany
Agaplesion Diakonieklinikum Hamburg
Hamburg, 20259, Germany
Gynäkologisch-Onkologische Gemeinschaftspraxis Dres. med. C.Uleer/J.Y.Pourfard
Hildesheim, 31134, Germany
Klinikum Konstanz
Konstanz, 78464, Germany
Universitätsmedizin Mainz
Mainz, 55131, Germany
Universitätsklinikum Mannheim
Mannheim, 68167, Germany
University Hospital Münster
Münster, 48149, Germany
Studienzentrum Onkologie Ravensburg
Ravensburg, 88212, Germany
SL Klinikum Rosenheim
Rosenheim, 83022, Germany
Leopoldina Krankenhaus der Stadt Schweinfurt
Schweinfurt, 97422, Germany
Universitätsklinik Ulm
Ulm, 89075, Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, 65199, Germany
AMO Wolfsburg / AMO MVZ GmbH
Wolfsburg, 38440, Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, 42117, Germany
Kantonsspital Aarau AG
Aarau, Canton of Aargau, 5001, Switzerland
Universitätsspital Basel
Basel, Canton of Basel-City, 4031, Switzerland
Oncology Institute of Southern Switzerland (IOSI)-Ente Ospedaliero Cantonale (EOC)
Bellinzona, Canton Ticino, 6500, Switzerland
Centre Hospitalier du Valais Romand
Sion, Valais, Switzerland
Kantonsspital Baden AG
Baden, 5404, Switzerland
Basel Claraspital AG
Basel, 4002, Switzerland
Universitätsklinik für Medizinische Onkologie, Inselspital
Bern, 3010, Switzerland
Praxis im Frauenzentrum Lindenhofspital
Bern, 3012, Switzerland
Kantonspital Graubünden (KSGR),
Chur, 7000, Switzerland
Kantonsspital Frauenfeld
Frauenfeld, 8501, Switzerland
Hôpitaux Universitaires de Genève
Geneva, 1205, Switzerland
Frauenklinik Spital Grabs
Grabs, 9472, Switzerland
Universitätsspital Waadt/ CHUV
Lausanne, 1011, Switzerland
Kantonsspital Baselland
Liestal, 4410, Switzerland
Luzerner Kantonsspital
Lucerne, 6000, Switzerland
Tumorzentrum Hirslanden Klinik St. Anna
Lucerne, 6006, Switzerland
Kantonsspital Münsterlingen
Münsterlingen, 8596, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, 9007, Switzerland
Kantonsspital Winterthur
Winterthur, 8401, Switzerland
Klinik für Onkologie und Hämatologie Hirslanden Zürich AG
Zurich, 8032, Switzerland
Stadtspital Triemli
Zurich, 8063, Switzerland
Unispital Zürich
Zurich, 8091, Switzerland
Related Publications (1)
McLaughlin PMJ, Klar M, Zwimpfer TA, Dutilh G, Vetter M, Marth C, du Bois A, Schade-Brittinger C, Reuss A, Bommer C, Kurzeder C, Heinzelmann-Schwarz V. Maintenance Therapy with Aromatase Inhibitor in epithelial Ovarian Cancer (MATAO): study protocol of a randomized double-blinded placebo-controlled multi-center phase III Trial. BMC Cancer. 2022 May 6;22(1):508. doi: 10.1186/s12885-022-09555-8.
PMID: 35524184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heinzelmann-Schwarz, Prof. MD PhD
University Hospital Basel, Head Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2019
First Posted
October 2, 2019
Study Start
November 5, 2020
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2032
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share